SSL Healthcare Manufacturing S.A.
⚠️ Moderate Risk
FEI: 3002731489 • Barcelona • SPAIN
FEI Number
3002731489
Location
Barcelona
Country
SPAINAddress
Avenida Can Fatjo, 151 08191 Rubi, , Barcelona, , Spain
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/17/2005 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is SSL Healthcare Manufacturing S.A.'s FDA import refusal history?
SSL Healthcare Manufacturing S.A. (FEI: 3002731489) has 6 FDA import refusal record(s) in our database, spanning from 11/17/2005 to 11/17/2005.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. SSL Healthcare Manufacturing S.A.'s FEI number is 3002731489.
What types of violations has SSL Healthcare Manufacturing S.A. received?
SSL Healthcare Manufacturing S.A. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about SSL Healthcare Manufacturing S.A. come from?
All FDA import refusal data for SSL Healthcare Manufacturing S.A. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.